Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
Information source: Ruttonjee Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspirin; Dyspepsia
Intervention: esomeprazole (Drug); Famotidine (Drug)
Phase: Phase 4
Sponsored by: Ruttonjee Hospital
Official(s) and/or principal investigator(s):
FH Ng, MD, Principal Investigator, Affiliation: Ruttonjee Hospital
FH Ng, M.D., Phone: 22911743, Email: email@example.com
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in
30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper
endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant
lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the
management is unclear. The objective of this study is to compare the efficacy of
esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent,
patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg
daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week.
The study will be completed at the 4th week. The primary analysis will be the efficacy in
the control of dyspepsia symptom between the two groups.
Official title: Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period
Secondary outcome: Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score
The objective of this double blinded randomized controlled study is to compare the efficacy
of esomeprazole with famotidine in the control of dyspepsia in patients with aspirin related
nonulcer dyspepsia NUD.
The study shall be applied for approval from the Ethic Committee of Hong Kong West and East
Cluster and shall be registered to the Clinical Trial Governance before the recruitment of
the first patient.
Measuring instruments & Definitions
Hong Kong Dyspepsia Index (HKDI)
The presence or absence of dyspepsia was measured by the validated Hong Kong index of
dyspepsia . This questionnaire could be used in epidemiological studies assessing the
frequency and severity of dyspepsia in patient populations and also in interventional
studies in functional dyspepsia. This index consisted of 12 questions on the severity of
gastrointestinal symptoms, graded according to a five-point Likert scale (1- 5, from
asymptomatic to very severe symptoms). A cut-off score of equal to or greater than 16 was
determined to discriminate between controls and dyspeptic patients.
Global Dyspepsia Score
The global severity of dyspepsia will be measured by the Global Dyspepsia Score, which was a
four-point scale in which a score of 0 indicated no pain or discomfort, a score of 1 mild
pain or discomfort, a score of 2 moderate (annoying but not interfering with the daily
routine) pain or discomfort, and a score of 3 severe (markedly interfering with the daily
routine) pain or discomfort over the last 7 days . This scale is reliable, valid, and
responsive and provides global assessment of symptoms in the western population .
Significant dyspepsia was defined when Global Dyspepsia Score was more than or equal to 2
Definition of significant endoscopic finding
Significant finding was defined as the presence of reflux esophagitis, Barrett's esophagus,
gastric or duodenal ulceration, duodenal or esophageal erosions, or cancer and those with
more than five gastric erosions on upper endoscopy. (Tally N, NEJM 1999)
Minimum age: 18 Years.
Maximum age: N/A.
- at least moderate pain or discomfort (or both) centered in the upper abdomen as their
predominant symptoms for 7 days before randomization; taking low dose aspirin (80-300
mg daily),and insignificant upper endoscopic finding. At least moderate pain or
discomfort is defined if the HKDI was more than or equal to 16.
- H. Pylori: In patients with have successful eradication of H. pylori and had
dyspepsia with HKDI >=16 at the 6th week after eradication therapy can be
recruited. In patients without H. pylori infection, they can be recruited immediately.
- non-Chinese speaking
- significant endoscopic finding
- typical biliary colic
- predominant heartburn or symptoms of the irritable bowel syndrome
- a history of peptic ulcer or gastroesophageal reflux
- unintentional weight loss previous gastric or duodenal surgery
- renal failure with estimated creatinine clearance less than 10 ml/min
- active cancer
- known allergic to aspirin, famotidine or esomeprazole
- pregnancy, lactation, child-bearing potential in the absence of contraception
- planned co-prescription of nonsteroidal anti-inflammatory drugs
- corticosteroid, clopidogrel or anticoagulant
- anxiety neurosis, depression, psychosomatic disorder
- investigation for dyspepsia with endoscopy or barium series before aspirin therapy or
disorders that might modify the absorption of study drugs
- ongoing treatment with a histamine H2-receptor antagonist, a prostaglandin, or a
prokinetic drug during the 7 days before enrollment was not permitted, nor was
treatment with a proton-pump inhibitor, or bismuth in the 30 days before enrollment
Locations and Contacts
FH Ng, M.D., Phone: 22911743, Email: firstname.lastname@example.org
Ruttonjee Hospital, Hong Kong, China; Recruiting
FH Ng, MD, Phone: 22911743
Queen Mary Hospital, Pokfulam, Hong Kong, China; Recruiting
Ivan Hung, Phone: 28551111
Starting date: September 2009
Last updated: June 5, 2012